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The purpose of this study is to test whether or not regular exercise training may improve brain blood flow regulation in patients with chronic kidney disease (CKD).
Prior research has shown that CKD patients have an increased risk of stroke and that impairments in brain blood flow regulation predict stroke in other chronic disease states. This study will test whether exercise training can improve brain blood flow regulation via improved dynamic cerebral autoregulation and cerebrovascular carbon dioxide reactivity in CKD. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Training | Experimental | Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session. |
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| Stretching | Placebo Comparator | Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Participants randomized to this arm will exercise on a stationary bicycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Phase (Radians) | Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity very low frequency phase (radians) | Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13). |
| Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Gain (cm/s/mmHg) | Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity data was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity gain (cm/s/mmHg). | Mean arterial pressure-middle cerebral artery blood velocity transfer function gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13). |
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Inclusion Criteria:
• Individuals with chronic kidney disease stages III-IV.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Texas | Denton | Texas | 76203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training | Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session. Exercise: Participants randomized to this arm will exercise on a stationary bicycle. |
| FG001 | Stretching | Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes. Stretching: Participants randomized to this arm will perform stretching and balance exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Training | Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session. Exercise: Participants randomized to this arm will exercise on a stationary bicycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Phase (Radians) | Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity very low frequency phase (radians) | Posted | Mean | Standard Deviation | Radians | Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13). |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training | Participants will exercise 3 times a week on a stationary bicycle. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) and increase as tolerated to a maximum of 80% of maximal heart rate reserve. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes per session. Exercise: Participants randomized to this arm will exercise on a stationary bicycle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justin Sprick | University of North Texas | 940-565-2226 | justin.sprick@unt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2025 | Jul 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Participants will be assigned to one of two conditions:1) aerobic exercise training on a stationary bicycle, or 2) stretching and balance training.
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| Stretching | Behavioral | Participants randomized to this arm will perform stretching and balance exercise. |
|
| BG001 | Stretching | Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes. Stretching: Participants randomized to this arm will perform stretching and balance exercise. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stretching | Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes. |
|
|
|
| Primary | Mean Arterial Pressure-Middle Cerebral Artery Blood Velocity Very Low Frequency Gain (cm/s/mmHg) | Mean arterial pressure was measured via finger photoplethysmography. Middle cerebral artery blood velocity data was measured via transcranial Doppler ultrasound. A transfer function analysis was performed on the mean arterial pressure and middle cerebral artery blood velocity data to derive mean arterial pressure-middle cerebral artery blood velocity gain (cm/s/mmHg). | Posted | Mean | Standard Deviation | Cm/s/mmHg | Mean arterial pressure-middle cerebral artery blood velocity transfer function gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13). |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Stretching | Participants will undergo progressive whole body stretching and balance exercises. This type of low intensity exercise is designed not to increase heart rate but rather to improve joint mobility and the ability to perform activities of daily living. This will serve as the control group to the exercise group. The control group will come in for stretching sessions 3 times per week for 20-45 minutes. Stretching: Participants randomized to this arm will perform stretching and balance exercise. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |